The Synchron Systems No Foam DxC — Class II medical device recall Z-2247-2016
Terminated recall by Beckman Coulter Inc., reported 2016-07-27, distributed in PR. Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropn
| Recall number | Z-2247-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-06-27 |
| Classified | 2016-07-20 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-08-25 |
| Distributed | PR |
| Countries outside the US | AE, AR, AU, BD, BE, BG, CA, CH, CN, CO, CR, CW, CZ, DE, EC, EG, ES, FI, FR, GB, GR, GT, HK, IE, IN, IQ, IT, JO, JP, KR, KW, LB, LT, MA, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SG, SK, TH, TN, TR, TW, VN, ZA |
Product
The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.
Reason for recall
Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2247-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.